Will TCM ever go main­stream?

While the most fa­mil­iar and widely used tra­di­tional Chi­nese medicine method (TCM) used in the United States is acupunc­ture, TCM’s use of her­bal for­mu­las has made few in­roads,
re­ports Dong Leshuo from Wash­ing­ton.

At the Karolin­ska In­sti­tutet in Stock­holm, one of the largest and most pres­ti­gious med­i­cal univer­si­ties in the world, hun­dreds of the world’s top med­i­cal re­searchers and prac­ti­tion­ers lis­tened as a Chi­nese lady spoke.

The speaker on Dec 7 was Youyou Tu, awarded the 2015 No­bel Prize in Phys­i­ol­ogy or Medicine “for her dis­cov­er­ies con­cern­ing a novel ther­apy against Malaria.”

Tu, the first Chi­nese na­tional to win a No­bel Prize, talked about how she with other Chi­nese sci­en­tists, ex­tracted the malaria-fight­ing com­pound Artemisinin from the plant Artemisia an­nua to treat Malaria.

She called her break­through “a suc­cess­ful ex­am­ple of col­lec­tive ex­plo­ration in Chi­nese medicine.”

“Artemisinin is a gift to the world from Tra­di­tional Chi­nese Medicine,” Tu said.

Shen­nong, an em­peror of China who is said to have lived about 4,500 years ago, is thought to have taught the an­cient Chi­nese the use of her­bal drugs. Chi­nese her­bal medicine, along with acupunc­ture and many dif­fer­ent prac­tices and ther­a­pies, make up Tra­di­tional Chi­nese Medicine (TCM).

For more than 4,000 years, TCM has been an in­te­gral part of Chi­nese cul­ture and the pre­dom­i­nant med­i­cal treat­ment for a large part of the world’s most pop­u­lous coun­try.

But the Chi­nese her­bal medicine, from which Tu ex­tracted Artemisinin to fight malaria, is still not a le­gal drug in the United States.

Twi­light zone

Chi­nese her­bal medicine con­tin­ued to re­main in the twi­light zone of med­i­cal treat­ment in the US un­til 1994 with the pas­sage of the Di­etary Sup­ple­ment Health and Education Act (DSHEA).

Pres­i­dent Bill Clin­ton signed the Act into law, say­ing that “af­ter sev­eral years of in­tense ef­forts, man­u­fac­tur­ers, ex­perts in nutri­tion, and leg­is­la­tors, act­ing in a con­sci­en­tious al­liance with con­sumers at the grass­roots level, have moved suc­cess­fully to bring com­mon sense to the treat­ment of di­etary sup­ple­ments un­der regulation and law.”

Un­der the act, Chi­nese her­bal medicine can only be sold to sup­ple­ment a diet, must be taken by the mouth and con­tain a di­etary in­gre­di­ent, which in­cludes vi­ta­mins, min­er­als and herbs or other botan­i­cals.

While the Chi­nese prac­tice of acupunc­ture is ac­cepted and prac­ticed widely in the US, it will be much harder for Chi­nese her­bal medicine to in­te­grate be­cause “there are all kinds of is­sues about safety around qual­ity con­trol,” said Ted J. Kaptchuk, a pro­fes­sor of medicine at Har­vard Med­i­cal School and au­thor of The Web that Has No Weaver: Un­der­stand­ing Chi­nese Medicine, a book on the the­ory and prac­tice of Chi­nese al­ter­na­tive medicine.

“The com­plex­ity of Chi­nese her­bal medicine is much more than acupunc­ture. It’s go­ing to be a much slower process for Chi­nese herbs,” said Kaptchuk, who went to Ma­cao to study TCM from 1971 to 1975 and grad­u­ated with a de­gree in Chi­nese Medicine.

In 2007, an edi­to­rial in the sci­en­tific jour­nal Na­ture de­scribed TCM as “largely just pseu­do­science, with no ra­tio­nal mech­a­nism of ac­tion for most of its ther­a­pies.”

“Tra­di­tional Chi­nese medicine has an enor­mous trea­sure of dif­fer­ent herbs for dif­fer­ent con­di­tions, which have been try­ing to be uti­lized in the Western world,” said Dr Brian Ber­man, a tenured pro­fes­sor of fam­ily and com­mu­nity medicine, di­rec­tor of the Univer­sity of Mary­land School of Medicine Cen­ter for In­te­gra­tive Medicine and pres­i­dent and founder of the In­sti­tute of In­te­gra­tive Health.

As a Western trained med­i­cal doc­tor who was look­ing for so­lu­tions to chronic dis­eases in par­tic­u­lar, Ber­man started to study acupunc­ture, and the Chi­nese ex­er­cises Taiqi and Qigong about 30 years ago.

“I think there are many chal­lenges. One of them is the qual­ity of prod­uct. Some of the her­bal com­pa­nies are very good. But some of the other prod­ucts are not as good, giv­ing the com­pa­nies a bad rep­u­ta­tion,” Ber­man said.

Tra­di­tional Chi­nese medicine has an enor­mous trea­sure of dif­fer­ent herbs for dif­fer­ent con­di­tions, which have been try­ing to be uti­lized in the Western world.”

Thou­sands of herbs

When it comes to Chi­nese her­bal medicine, a sin­gle for­mula is usu­ally com­posed of many herbs, each of which has nu­mer­ous chem­i­cal com­pounds. Thou­sands of herbs — mainly plant but also an­i­mal and min­eral prod­ucts — are used in TCM. They can be taken as cap­sules, pow­ders or tea. If taken in the wrong dose, they can be toxic.

There is con­cern about qual­ity con­trol and the con­sis­tency of her­bal prepa­ra­tion be­cause qual­ity and chem­i­cal con­stituents vary from field to field, sea­son to sea­son and one ex­trac­tion process to an­other.

Due to inherent dif­fer­ences in how Western medicine and TCM are prac­ticed, em­ploy­ing the Western medicine-based gold stan­dard re­search meth­ods to eval­u­ate TCM is chal­leng­ing, said Ber­man.

“Many pa­tients are be­ing told by their doc­tors that we don’t re­ally know about th­ese ther­a­pies. They are not col­lec­tively in­tro­duc­ing them,” Ber­man said. “We have large clin­i­cal tri­als. We have a very long clin­i­cal trial of acupunc­ture and there is a pub­lished pa­per that it is a safe in prac­tice,” he said.

Ber­man said that it is even hard to do re­search on her­bal medicine.

“When we de­cided to do a Chi­nese her­bal for­mula study, it was hard for us to re­cruit peo­ple to do the study. Be­cause peo­ple were con­cerned about whether the medicine would con­tam­i­nate them,” Ber­man said.

“Get­ting the fund­ing to do the re­search is also a chal­lenge, but I think the chal­lenges are get­ting eas­ier and eas­ier. There was a huge chal­lenge to even study it. Peo­ple asked what it was like and why are you do­ing this. Now I think peo­ple re­al­ize we have to look at that. Peo­ple are suf­fer­ing from a lot of prob­lems that we don’t have the an­swers to, so we have to look widely be­cause Chi­nese her­bal medicine has a lot to of­fer. And I think we should keep costs at a low level so that it will not be so ex­pen­sive,” Ber­man said.

Ma­jor prob­lem

In­sur­ance com­pa­nies pose an­other ma­jor prob­lem to the le­git­i­macy of TCM in the US. A pa­tient can make an in­sur­ance claim for acupunc­ture but not for her­bal treat­ment.

“Most of the time, acupunc­ture works best with medicine. That’s why acupunc­tur­ists in China usu­ally also pre­scribe Western medicine as well as her­bal medicine to the pa­tients. But in the US, with­out an MD li­cense, the acupunc­tur­ist can­not pre­scribe the Western medicine. We can give the pa­tient her­bal medicine, but the cost must be cov­ered by the pa­tient,” said Dr Quan­sheng Lu, who worked in China as a doc­tor spe­cial­iz­ing in TCM for 14 years and is a li­censed acupunc­tur­ist in Rockville, Mary­land.

He said one of the chal­lenges fac­ing TCM in the US has been po­si­tion­ing it in the health sys­tem, whereas in China it is a main­stream med­i­cal and health so­lu­tion. Lu thinks more com­mu­ni­ca­tion and pro­mo­tion of TCM needs to be done in the US to put it on equal foot­ing with its use in China.

Many Chi­nese reme­dies ap­pear to have sig­nif­i­cant ther­a­peu­tic value and some work on con­di­tions for which Western doc­tors have no phar­ma­ceu­ti­cal drugs, ac­cord­ing to Dr An­drew Weil, a long­time pro­po­nent of TCM to treat a wide range of con­di­tions.

“Peo­ple use TCM for dis­eases that have not been suc­cess­fully treated by mod­ern medicine. Some­times for dis­eases when there is no other kind of treat­ment avail­able,” Kaptchuk said.

One of Lu’s pa­tients was a se­nior ex­ec­u­tive at an in­ter­na­tional or­ga­ni­za­tion in Wash­ing­ton. He had been suf­fer­ing from eczema for a long time and the con­di­tion se­ri­ously af­fected his life and work. De­spite see­ing dozens of der­ma­tol­o­gists in the area, in­clud­ing some spe­cial­ists at es­tab­lished med­i­cal in­sti­tu­tions such as the Johns Hop­kins Hos­pi­tal, noth­ing helped.

Lu said he treated him with acupunc­ture and her­bal medicine in 2014, and af­ter a month, the man was fully cured.

“I think they (Amer­i­can pa­tients) are look­ing for treat­ments that are safe and ef­fec­tive and that work par­tic­u­larly for some of the chronic dis­eases like di­a­betes and pain prob­lems,” Ber­man said.

“Things like pain are prob­a­bly the most im­por­tant to be treated by acupunc­ture. For her­bal medicine, func­tion dis­or­ders would be Kaptchuk said.

To get ac­cepted in the US, Ber­man said TCM will have to un­dergo a “gold stan­dard” med­i­cal trial and ef­fi­cacy study.

“I think acupunc­ture and other forms of TCM can be shown that they are ef­fec­tive to treat dis­eases. I think with­out that (the trial), it won’t be ac­cepted so much. If they (TCM) re­ally want to go to the main­stream, they have to go through clin­i­cal tri­als and be eval­u­ated in that way,” Ber­man said.

He said sev­eral Chi­nese her­bal medicine tri­als have been done and are be­ing done in dif­fer­ent parts of the world. “Among them, there are about 35 Chi­nese medicines in trial in ar­eas such as for headaches,” Ber­man said.

im­por­tant,”

Dan­shen Drip­ping Pill

In the US, the one that is the clos­est to the fin­ish line is the com­pound Dan­shen Drip­ping Pill, a Chi­nese her­bal treat­ment for angina and coro­nary heart dis­ease. It suc­cess­fully com­pleted the FDA’s Phase II clin­i­cal tri­als in July 2010. Once it passes Phase III in­ves­ti­ga­tions, which would most likely hap­pen in this year, it would be the first Chi­nese medicine to be­come a pre­scrip­tion drug in the US.

This would be an FDA en­dorse­ment of the her­bal com­bi­na­tion to treat po­ten­tially se­ri­ous ill­nesses, said Mark Blu­men­thal, founder and ex­ec­u­tive di­rec­tor of the Amer­i­can Botan­i­cal Coun­cil, ac­cord­ing to an ear­lier ar­ti­cle pub­lished in 2014 in China Daily.

The Dan­shen Drip­ping Pill is one of the prod­ucts pro­duced by Tasly Phar­ma­ceu­ti­cals, Inc that it calls “mod­ern Tra­di­tional Chi­nese Medicine (mTCM)”.

“The first thing we did to get it ap­proved was to build a solid foun­da­tion in sci­ence and col­lect enough ev­i­dence,” said Henry Sun, pres­i­dent and CEO of Tasly, based in Rockville, Mary­land. “Our goal is to bring our well-ev­i­denced mTCM prod­ucts to ben­e­fit Amer­i­can pa­tients. “

Sun said he be­lieves that the de­vel­op­ment of chem­i­cal phar­ma­ceu­ti­cals has been slow­ing down and reached a bot­tle­neck be­cause lead com­pounds, new struc­tures and dis­ease tar­gets have been ex­plored ex­ten­sively. “But in a way, mTCM is all nat­u­ral, and it pro­vides a new, sig­nif­i­cant re­source for the dis­cov­ery and de­vel­op­ment of phar­ma­ceu­ti­cals,” he said.

“If the Dan­shen Drip­ping Pill is ap­proved by the FDA, I be­lieve there will be lots of phar­ma­ceu­ti­cal com­pa­nies do­ing re­search on it. They may de­velop new chem­i­cal phar­ma­ceu­ti­cals from it. In this sense, the Chi­nese medicine, which is based on ex­ten­sive clin­i­cal ex­pe­ri­ences, could con­trib­ute a whole repos­i­tory to sci­ence and clin­i­cal re­search in the fu­ture,” Sun said.

And in her speech in Stock­holm, Tu said: “If we in­herit and keep de­vel­op­ing (TCM), there will be new find­ings and in­ven­tions which will ben­e­fit ev­ery hu­man be­ing.”

Con­tact the writer at leshuodong@chi­nadai­lyusa. com

Pan Jialiang in Wash­ing­ton con­trib­uted to the story.

PRO­VIDED TO CHINA DAILY.
— CHINA DAILY

Dr Quan­sheng Lu, an acupunc­tur­ist, at his Chi­nese her­bal phar­macy in the Wholelife Chi­nese Medicine and Acupunc­ture Cen­ter in Rockville, Mary­land, on Dec 8. In Jan­uary 2014, the Cleve­land Clinic, one of the coun­try’s top hospi­tals, opened its her­bal clinic. It is part of Ohio hos­pi­tal’s Cen­ter for In­te­gra­tive Medicine, which also pro­vides acupunc­ture, holis­tic psy­chother­apy and mas­sage ther­apy. “Western medicine does acute care phe­nom­e­nally.… But we’re still strug­gling a bit with our chronic-care pa­tients and this fills in that gap and can be used con­cur­rently,” Melissa Young, an in­te­gra­tive medicine physi­cian at the clinic told The Wall Street Jour­nal in a story pub­lished in April 2014. To be treated, pa­tients must be re­ferred by a doc­tor and will be mon­i­tored to en­sure that there are no drugherbal in­ter­ac­tions or other com­pli­ca­tions. Osher Cen­ter for In­te­gra­tive Medicine at North­west­ern Univer­sity and NorthShore Univer­sity HealthSys­tem, af­fil­i­ated with the Univer­sity of Chicago, both in­clude her­bal medicine among their of­fer­ings.